Novel Food Registration

Novel foods or ingredients (New Dietary Ingredients [NDI]) are those foods or ingredients which are not widely consumed enough to be considered safe. These include innovative food technologies and food from natural sources like animals, plants, microbes, and even mineral sources not traditionally being used in human diets. Compliance entails novel food ingredient registration, pre-market safety assessment, and listing according to country-specific regulations before market entry. Having a trusted Regulatory partner is crucial for navigating the intricacies of novel food registration and ensuring success.

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Novel Food Registration - Overview

Navigating the complex landscape of novel food products requires a trusted Regulatory partner. Novel foods or novel ingredients (New Dietary Ingredients [NDI]) are defined as those foods or ingredients that have not been significantly consumed to be considered safe. Depending on national novel food regulations, this category may include all foods obtained using innovative food technologies or derived from animals, plants, microbes, or mineral sources not currently used for human consumption. Before a novel food or ingredient can be legally marketed, it must have novel food ingredient registration, pre-market safety assessment, and listing in accordance with country-specific regulations.

This requirement applies to any food or food ingredients that have not been used in the market for human consumption to a significant degree before a particular year (each country will have a different year).

Novel Food Product Categories

  • Ingredients with new or modified molecular structures.
  • Micro-organisms, fungi, algae, or cell cultures.
  • Plants or animals.
  • Foods from new processes that alter nutritional properties or pose risks.
  • Minerals or engineered nanomaterials.

US Market Entry: NDIN and GRAS Notification

Businesses entering the United States (US) with supplements or new ingredients must navigate the New Dietary Ingredient Notification (NDIN) requirements. Moreover, understanding the specifics of a successful US FDA notification is equally critical. The US categorizes food ingredients as additives or Generally Recognized as Safe (GRAS). Freyr, with its Regulatory expertise, excels in the US FDA food facility registration and in streamlining US agent identification.

Partner with Freyr for novel food consultation, as we facilitate seamless global product integration, ensuring compliance and safety. Our experienced Regulatory team supports NDIN processes, reviews ingredient data, addresses gaps, prepares submissions, and aids in interactions with the US FDA. Freyr extends its Regulatory expertise to GRAS notifications and acts as a US FDA facility agent, aiding novel food processing and helping businesses in regulated markets globally, including the European Union (EU), Australia, New Zealand, India, Singapore, and the US.

Novel Food Registration

  • Preliminary feasibility assessment to determine suitability as a novel food/novel ingredient/ NDI.
  • Novel food ingredient review – complete data review.
  • Review of documents as per the guidelines of respective Health Authorities (HAs) for submission/notification.
  • Application submission for novel food ingredient registration.
  • Communication and follow-up with HAs.
  • A qualified team of experts with hands-on experience in novel food and ingredient registration.
  • Expertise in online submission and local support expertise in novel food and ingredient registration.
  • Novel food ingredient registration/identification and Regulatory consulting on the registration process.
  • End-to-end Regulatory consultation for novel food application/registration and novel food ingredient registration.
  • Has rapport with HAs for novel food ingredient registration.
  • Support for region-specific Regulatory complexities in novel food approval.
  • An extensive partner network across the globe.
  • A strong relationship with different HAs.
  • Cost-effective consultation services.